The role of a sponsor “They expect WHAT?!”
Industry-Sponsor and clinical research organizations (CROs) work collaboratively to execute successful clinical trials. Understanding the roles and expectations of each can create positive synergy and impactful results.
Sponsors are responsible for initiating and overseeing the entire clinical trial process: the trial’s design, conduct and outcome. They ensure that the trial adheres to regulatory guidelines and ethical standards. Sponsors may collaborate with CROs to manage certain aspects of the trial such as protocol design, site selection, patient recruitment, and monitoring of progress. CROs may assume one or more obligations of the sponsor in addition to providing their clinical development and operational knowledge, and experience.
As a principal investigator, have you ever had instances in which you thought the sponsor had too many requirements? Or they asked you to redo things you thought were clear or resolved? When challenges arise, they can often be traced to misunderstandings and unarticulated expectations between sponsors and the clinical site. Below are three specific areas that sponsors wish all clinical sites focused on to ensure the clinical study runs smoothly.
Qualified site personnel
The sponsor is looking for a principal investigator who has experience conducting clinical trials, but also qualified clinical staff personnel. Most of the groundwork is performed by the clinical study coordinator and supporting study staff. Having experienced clinical study staff personnel is key to running the clinical trial effectively. Many sponsors will return to a clinical site for future studies if the clinical site met the recruitment target goals and if clinical staff personnel were on top of data entry, provided quick turnaround of query resolution, and kept clinical study files current.
2. Audit
A clinical site can be audited at any time by regulatory authorities such as the FDA, ethics committee, and the sponsor. These audits can be scheduled or unannounced. Make sure the investigator binder is current and available, equipment used in the study is up to date and calibrations current, investigational product is accounted for, and study personnel is qualified and follows good clinical practice. The FDA has great resources available, so you and your team are always audit-ready. Below is a 2023 list of the most common clinical investigator observations per FDA:
Failure to comply with form FDA 1572 requirements; failure to follow the investigational plan
Inadequate and/or inaccurate case history and study records
Inadequate subject protection; informed consent issues
Inadequate investigational product accountability
Failure to report and/or record adverse events
3. Enrollment requirements and timelines
Enrollment thresholds and timelines are metrics the sponsor uses to monitor clinical site performance and gauge duration of the clinical trial. Unexpected and unforeseen delays may occur, but it is critical the clinical site communicates these delays to the sponsor as quickly as possible. The sponsor will use this information to provide the clinical site with additional support that may help increase participant recruitment and participant engagement such as creation of educational materials that can be handed to participants.
Being in front of innovations that may one day make huge improvements for your patients is very rewarding. However, conducting a clinical trial is a big responsibility and can add additional time to your already busy schedule. Keep open and regular communication with the sponsor, who will work very closely with you and your team until study completion.
Sponsors can’t get products to market without your help. By collaborating effectively, sponsors and investigators can harness each other's strengths and maximize overall success.
Contact us If we can assist you with your clinical trial.
References
Bioresearch Monitoring (BIMO) Fiscal Year 2023 Metrics. (2024, November 06). Retrieved from U.S. Food and Drug Administration: https://www.fda.gov/media/178661/download?attachment
CFR - Code of Federal Regulations Title 21. (2024, August 30). Retrieved from U.S. Food and Drug Administration: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=312&showFR=1
